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A Double-Blind, Controlled Study of Aripiprazole in Co-Morbid Schizophrenia and Cocaine Dependence

Information source: Denver Research Institute
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Schizophrenia; Cocaine Dependence

Intervention: Aripiprazole (Drug); Perphenazine (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Paul Saenger

Official(s) and/or principal investigator(s):
Thomas P Beresford, MD, Principal Investigator, Affiliation: Denver Veteran's Affairs Medical Center

Overall contact:
Jennifer Ratzlaff, MA, Phone: 303-399-8020, Ext: 3855, Email: Jennifer.Ratzlaff@ucdenver.edu

Summary

The purpose of this study is to gather systematic clinical data on whether aripiprazole, a partial dopamine agonist, beneficially affects schizophrenia plus cocaine dependence subjects. Since aripiprazole has established effects against schizophrenia, the study focuses on whether aripiprazole concurrently reduces co-morbid cocaine dependence in schizophrenia plus cocaine dependence sufferers compared to a standard typical antipsychotic treatment (perphenazine). The working hypothesis states that subjects in the aripiprazole treatment arm of the study will give fewer cocaine positive urine specimens as compared to the perphenazine control arm.

Clinical Details

Official title: A Double-Blind, Controlled Study of Aripiprazole in Co-Morbid Schizophrenia and Cocaine Dependence

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: The proportion of negative urine drug screen results will be significantly greater in the subjects treated with aripiprazole than in those treated with perphenazine.

Secondary outcome:

The mean total self-report cocaine use days will be significantly fewer in subjects treated with aripiprazole than in those treated with perphenazine.

The mean cocaine craving scores will be lower in subjects treated with aripiprazole than in those treated with perphenazine.

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Have a primary DSM-IV diagnosis of Schizophrenia or Schizoaffective disorder 2. Have a DSM-IV diagnosis of current cocaine dependence. 3. Are capable of reading, comprehending, and signing informed consent. 4. Agree to take Aripiprazole or Perphenazine as treatment for SCHZ and CD. 5. Agree to stop taking any other antipsychotic medication 6. If female and of child bearing potential (WOCBP) agree to use an acceptable form of birth control and have a negative pregnancy test within 2 days prior to starting study medication Exclusion Criteria: 1. Under 18 years old or over 65 years old. 2. Refusal or inability to give informed consent, 3. Have a history of myocardial infarction or ischemic heart disease, heart failure or conduction abnormalities, cerebrovascular disease, or conditions that would predispose to hypotension (dehydration, hypovolemia), 4. A history of seizures or conditions that lower the seizure threshold 5. Have current suicidal ideation (history of suicide attempt in past 60 days) 6. Are actively psychotic which in the opinion of the investigator would preclude proper informed consenting or protocol adherence 7. Are receiving or plan to receive an agent metabolized by the Cytochrome P450-3A4 or

- 2D6 systems, including carbamazepine, ketoconazole, quinidine, fluoxetine, and

paroxetine 8. WOCBP not on, or do not agree to use an acceptable form of contraception 9. Known sensitivity to aripiprazole or perphenazine 10. A diagnosis of current or past tardive dyskinesia 11. Pending legal charges or a court mandate for drug treatment 12. Currently taking concomitant medications that have been shown to reduce cocaine use, such as disulfiram 13. Clinically significant liver function abnormalities 14. Currently receiving depot neuroleptics

Locations and Contacts

Jennifer Ratzlaff, MA, Phone: 303-399-8020, Ext: 3855, Email: Jennifer.Ratzlaff@ucdenver.edu

Veteran's Affairs Medical Center, Denver, Colorado 80220, United States; Recruiting
Lori Clapp, RN, MS, Phone: 720-854-4200
Additional Information

Starting date: August 2008
Last updated: September 6, 2012

Page last updated: August 23, 2015

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